Это пример для тех, кто думает, что фармфирмы всех купили. Нет, не всех.
UK Cardiologists Petition NICE to Reverse Dronedarone Decision
Sue Hughes
Authors and Disclosures
February 4, 2010 (London, United Kingdom) — UK cardiologists and arrhythmia patient groups are petitioning the UK National Institute for Health and Clinical Excellence (NICE) in an attempt to persuade the agency to allow National Health Service (NHS) prescribing of the new antiarrhythmic agent dronedarone (Multaq, Sanofi-Aventis) for the treatment of atrial fibrillation (AF). The matter has also been discussed in Parliament.
NICE, which dictates how a drug can be prescribed with UK government funding, issued a draft guidance on dronedarone on December 24, 2009, as covered by heartwire , saying that it did not recommend use of the drug to treat AF, because "it is less effective and costs considerably more than existing treatments. [1,2]" It is estimated that dronedarone costs around £2.25 per day compared with about £0.05 for amiodarone.
After a draft guidance is issued, NICE invites comments from interested parties, which are considered at a second NICE panel meeting; this will be held for dronedarone on February 24, 2010. After this second meeting, a final guidance will be issued, but this takes a few weeks. Sanofi-Aventis told heartwire that it expects to receive the final guidance sometime between March and May. If the final guidance is the same as the draft guidance, which is usually the case, then dronedarone will not be available for general NHS prescribing.
Parliamentary Activity
More than 100 doctors have signed an open letter to NICE setting out why they believe the drug should be available for NHS prescription. A Parliamentary Stakeholder Investigation was held in the House of Commons yesterday, instigated by Members of Parliament (MPs) John Maples and Paul Keetch, to enable patients, clinicians, and managers to vocalize their concerns about the negative guidance, discuss the clinical and cost-effectiveness of dronedarone, and consider arguments about innovations in healthcare.
A Parliament Early Day Motion has also been drawn up and signed by 24 MPs so far. The motion sets forth that "dronedarone is a first-in-class antiarrhythmic drug and the only antiarrhythmic medication known to improve long-term cardiac health in AF patients" and that "many people with AF who currently struggle to manage the condition would benefit from access to this treatment, and its use would yield considerable cost savings in the longer term through reduced hospital admissions and reduced incidence of stroke."
These efforts have been coordinated by the arrhythmia patient/professional groups, the Atrial Fibrillation Association (AFA) and Heart Rhythm UK. A spokesperson for the AFA told heartwire that the purpose of the parliamentary activity was to draw attention to the matter and to call on NICE to ensure that all the available clinical evidence is considered at the second meeting on dronedarone and that an arrhythmia specialist is present to explain in more detail why the drug is needed. While this would normally happen at the first panel meeting, in this case no arrhythmia expert was available for the first meeting; however, there were presentations from the company and patient groups and a written submission from a heart-rhythm specialist.
I don't think anyone is insensitive to the fact that we have to keep costs down.
One of the cardiologists involved in the campaign and who spoke at the House of Commons yesterday is arrhythmia specialist Prof John Camm (St George's Hospital Medical School, London, UK).
He told heartwire that he was generally supportive of NICE decisions, but in this case he believes it has gotten it wrong. "I don't think anyone is insensitive to the fact that we have to keep costs down and that we have to have a NICE-type process. I generally agree with it. But I think they made the wrong call here. This view is shared by most other clinicians, who also believe we should have this drug available," he said.
Camm noted that dronedarone has been studied in the largest trial ever done of an antiarrhythmic agent in AF--the 4500-patient ATHENA study--which he said showed "highly positive results," with a 24% relative risk reduction vs placebo in the primary composite end point of time to first cardiovascular hospitalization/all-cause mortality. Other smaller trials (ADONIS and EURIDIS) have shown a moderate efficacy of dronedarone vs placebo in the time to first recurrence of AF, and the DIONYSUS trial showed that dronedarone may not have been as effective as amiodarone in preventing recurrent AF but seemed to produce fewer adverse effects, he added. Preliminary results from DIONYSUS have been released by Sanofi, as reported by heartwire , but have yet to be published. Dronedarone was approved by the European Medicines Agency last autumn for the treatment of recurrent AF.
"Not surprisingly, because it has been put through a very thorough investigation, largely at the behest of regulators and the clinical community, who required a cardiovascular-outcomes trial, this drug is expensive," Camm said. He added: "It's not seen as the most powerful antiarrhythmic agent or as a drug that will cure all conditions associated with AF, but it is seen as a new drug with a new spectrum of activity that is particularly safe; it would give us a new option in the treatment of symptomatic AF. And if it were not effective, patients would come off it, so they don't spend a lot of time wasting money."
New Options Urgently Needed
He continued: "The point that NICE didn't bear in mind is that many patients with AF can tolerate only one drug at most, as they have underlying cardiac conditions that prevent the use of many of the antiarrhythmics. This applies particularly to patients with mild to moderate heart failure who can't take flecainide, propafenone [Rythmol, Reliant], or sotalol, so the only option left is amiodarone. In addition, patients with ischemic heart disease can't take flecainide or propafenone, and many patients with hypertension can't take sotalol. As ischemic heart disease and hypertension commonly occur together, this again leaves another large group of patients with amiodarone as the only antiarrhythmic drug choice. So the options for many patients are completely limited. And it is that point that I think was lost in the NICE discussions.
Many patients with AF can tolerate only one drug at most, as they have underlying cardiac conditions that prevent the use of many of the antiarrhythmics.
"I don't think it would be used anything like amiodarone, but we do need a safe alternative to amiodarone with a different mechanism of action to try in different patients," Camm added.
He said there had therefore been a lot of activity leading up to the second NICE panel meeting later this month. "The patient and professional organizations that are stakeholders in the NICE process have been fulfilling their function and feeding back their concerns." These organizations include representatives of patients, doctors, nurses, technicians, and industry. While industry does contribute toward funding of these groups, many different companies are involved, not just Sanofi-Aventis, Camm noted. "While of course Sanofi-Aventis is participating in these activities, I don't believe that we doctors are dancing to the tune of the company particularly. If we were, we would be taking a much harder approach.
"NICE can change their ruling from the preliminary decision to the final decision. There certainly is the precedent for this, and I am hopeful that they will this time."
Would Reduction in Hospitalization Compensate for Drug Costs?
Asked whether the reduction in hospitalization seen in ATHENA would pay for the drug, Camm replied that cost-effectiveness models have of course looked at this, but it depends a lot on which economy is used (ie, which country). "The company did one analysis, and then the NICE team did their own. I think there was concern about extrapolating the data across the large majority of AF patients."
NICE is obviously concerned that giving a green light to dronedarone would result in it being prescribed to a large patient population, amounting to a very large bill to the government. But Camm says he doesn't think that will be the case. "Nobody is intending to do a wholesale transfer of all their patients from their current drugs onto the new one. We would just like it to be part of the armamentarium. Clinical use for a few years will rapidly determine how avidly it is used."
He estimates that 1% to 2% of the general population has AF (around one million in the UK), and of those, as many as 30% could benefit from an antiarrhythmic drug. "But I wouldn't imagine that more than a small proportion of that group would be particularly well managed by dronedarone. My own viewpoint is that you could try it, and if it keeps the arrhythmia at bay it will be a very good drug because of its safety profile. But NICE will probably want to position it lower down in the medical triage."
Camm believes the NICE process could be strengthened by having more experts on its committees. He explained that NICE has the policy of using a committee of people who are largely not particularly knowledgeable of the situation, and they then listen to the evidence. For example, the panel reviewing dronedarone included only one cardiologist, who was not an arrhythmia specialist. Experts are invited to talk, and it was unfortunate in this case that no arrhythmia specialist was available to attend the first meeting.
A NICE spokesperson gave the following statement to heartwire : "The dronedarone consultation has now closed, and all submissions received will be considered and presented at the next committee meeting. We don't have anything more to add to this until the next stage in the process, so we won't be issuing any further comment at this point."
Sanofi-Aventis told heartwire that dronedarone had been launched in four countries so far--the US, Canada, Germany, and Switzerland. "In two of these countries that have government reimbursement systems--Germany and Switzerland--dronedarone is being reimbursed," the company said. On the situation in the US, Sanofi-Aventis said: "Multaq has been accepted by a number of the large payer groups to provide unrestricted tier 2 access for many Medicare patients covered by Part D plans."
The company noted that in Canada, the process is for the Common Drug Review (CDR) committee to give a recommendation on reimbursement, and each province then decides whether to follow it. The CDR has not yet announced its recommendation on dronedarone. Quebec is different in that there the Conseil du médicament makes a first assessment, and it has acknowledged the therapeutic value of dronedarone and also agreed that the reduction of hospitalization is a more important clinical outcome than AF recurrence, but it has requested an economic analysis comparing dronedarone with amiodarone, which the company is now developing.
Camm has acted as a consultant and a speaker for Sanofi-Aventis.
http://www.medscape.com/viewarticle/716 ... c=116880SK
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Танюша, не лукавьте, лучше меня ведь спикаете?